Terminated

GE Healthcare CT/e and HiSpeed X/i, families of computed tomography Systems with Gantry. The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

FDA Recall Z-2224-2009 · Posted 2009-09-18

Recalling FirmGE Medical Systems, LLC

Recall StatusTerminated

Product CodeJAK

Date Initiated2008-12-01

Date Terminated2016-01-27

Product Quantity7005 units (787 US, 6218 OUS)

Reason for Recall

During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the Code of Federal Regulations, and IEC 60601-1-3, related to leakage radiation from the diagnostic source assembly, which includes the collimator. The excess leak

Firm Action

GE Healthcare issued an "Important - Electronic Product Radiation Warning" to affected customers. GE Healthcare field service representative will perform a field corrective action on all affected units. All potential users of the device should be made aware of the notification and the information contained. For further information, contact GE Healthcare at 1-800-437-1171 (US) or by contacting your local GE Healthcare service manager.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution -- UNITED STATES (AL, AZ, AR, CA, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MA, MI, LMN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, PA, PR,SC, SD, TN, TX, VA, WA, WV and WI), ALGERIA, ANTIGUA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BENIN, BOLIVIA, BOSNIA & HERZEGOVINIA, BRAZIL BULGARIA, BYELORUSSIAN, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK , DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COST, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, , MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITANIA, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGER, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIAN F=FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND , SYRIA ARAB REPUBLIC, TAIWAN, THAILAND, TRINIDAD & TOBAGO TUNISIA, TURKEY,, UGANDA, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN and YUGOSLAVIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021491HISPEED DUALGe Medical Systems, Inc. · 2002-05-22 K993645CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEMGe Medical Systems, Inc. · 1999-12-21 K991716HISPEED NX/I CT SCANNER SYSTEMGe Medical Systems, Inc. · 1999-06-18 K980169HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMSGeneral Electric Co. · 1998-04-13 K944013CT PROSPEED FAMILYGE Medical Systems · 1995-02-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.